Pharmaceutical
GMP warehouse, FEFO and native regulatory traceability.
GMP
Compliant
FEFO
Automatic
IQ/OQ/PQ
Documented
100%
Audit trail
The challenge
GMP, FEFO and controlled temperature.
Pharmaceutical logistics operates under the world's most demanding regulations. DELIE systems for the GMP warehouse are designed to comply with GMP, 21 CFR Part 11 and ANMAT regulations with no additional configuration.
"In pharma, compliance is not optional. The system has to guarantee it by design, not by process."
Why automate
Key benefits
GMP warehouse by design
Automatic recording of every movement with user, timestamp and location for a complete, immutable audit trail.
Automatic FEFO
The system prioritizes by expiry date at every dispatch with no operator intervention. 100% guaranteed compliance.
Controlled temperature
Differentiated zones for refrigerated (2-8°C), controlled (15-25°C) and frozen (-20°C) within the same pharma depot.
Role-based access control
Access restricted by zone and operation type with second factor for controlled products. 21 CFR Part 11 compatible.
ANMAT serialization
Unit-level medicine traceability module that meets ANMAT pharmaceutical serialization requirements in Argentina.
IQ/OQ/PQ documentation
DELIE delivers pre-built DQ, FS and DS. STOKA supports the qualification process to meet regulatory deadlines.
Before & after
Without automation
GMP compliance with immutable audit trail in every GMP warehouse movement
Strict FEFO with multiple lots and expiry dates
Temperature and humidity control with continuous records
Controlled access and medicine/operator traceability for 21 CFR
Unit serialization for ANMAT medicine traceability
Long and costly IQ/OQ/PQ qualification process
With STOKA · DELIE
GMP-compliant WMS with user and timestamp audit trail
Automatic FEFO with lot-level expiry alerts
Differentiated temperature zones with continuous monitoring
Role-based access control with second factor for controlled products
Unit serialization module compatible with ANMAT
DQ/FS/DS validation documentation pre-built by DELIE
Automation context
Warehouse automation in pharmaceutical
The pharmaceutical warehouse is the most regulated environment in pharmaceutical logistics. National (ANMAT in Argentina) and international (FDA, EMA, WHO GDP) regulations require complete medicine traceability of each unit from receipt to dispatch, temperature and humidity control with continuous records, and role-based controlled access with an immutable audit trail in the GMP warehouse.
DELIE's GMP-compliant WMS meets 21 CFR Part 11, EU GMP Annex 11 and ANMAT requirements. For laboratories, drug wholesalers and pharmaceutical distributors in Argentina and Chile, automating the pharma depot with STOKA includes pre-built IQ/OQ/PQ documentation that significantly reduces the time and cost of the regulatory qualification process.
GMP
Compliant
FEFO
Automatic
IQ/OQ/PQ
Documented
100%
Audit trail
Recommended equipment
Products for this sector
FAQ
Frequently asked questions about automation
Does the system comply with GMP and ANMAT regulations for the GMP warehouse?
Yes. The WMS includes a GMP module that records every movement with user, timestamp, origin and destination location. This audit trail complies with 21 CFR Part 11, EU GMP Annex 11 and ANMAT requirements.
How does role-based access control work in the pharma depot?
Each operator has unique credentials with permissions by zone, operation type and product. The system records who did what and when in every movement, guaranteeing medicine traceability.
Can differentiated temperature zones be created in the same depot?
Yes. The system allows defining logical zones with specific temperature requirements (2-8°C, 15-25°C, -20°C) within the same GMP warehouse. Temperature monitoring is continuous with automatic alerts on deviations.
How long does it take to validate the system for GMP in a pharma depot?
IQ/OQ/PQ validation takes between 3 and 6 months post-installation. DELIE delivers validation documentation (DQ, FS, DS) with the system.
Does the system manage the unit serialization required by ANMAT?
Yes. The WMS serialization module reads and records the barcode or 2D DataMatrix of each unit in receiving, storage and dispatch operations, ensuring medicine traceability.
Can the system be used in a wholesaler with GDP authorization?
Yes. The DELIE WMS has been qualified in facilities with GDP authorization in Latin America.
How are expired or recalled medicines handled?
The WMS has a specific quarantine and destruction flow: blocked products are logically segregated, with automatic dispatch blocking and notification to the regulatory officer.
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